SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE),
a leading cell therapy company, today highlighted the publication of
results in the Journal
of Clinical Oncology from a National Cancer Institute (NCI) study
evaluating the safety and efficacy of a MAGE A3 T cell receptor (TCR)
engineered T-cell therapy. The cancer testis antigen MAGE A3 is
frequently found in many cancers including bladder, esophageal,
cervical, head and neck, lung, and ovarian cancers, among others. The
research, led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery
Branch at NCI’s Center for Cancer Research, was performed, in part,
pursuant to a Cooperative Research and Development Agreement (CRADA)
between NCI and Kite.

In this dose-escalation study, 17 patients with a variety of metastatic
solid tumors were treated with a single dose of a MHC class II
(HLA-DPB*0401)-restricted MAGE A3 TCR engineered T-cell therapy after a
chemotherapy conditioning regimen. Responses were observed in 4
patients, including a complete remission (CR) in a patient with
metastatic cervical cancer that is ongoing at 29 months. Among the 9
patients treated at the target dose level, evidence of tumor regression
was seen in 3 patients with esophageal cancer, urothelial cancer, and
osteosarcoma. All three responders had significant levels of the TCR
engineered T cells in blood, at 1 month post-treatment. The patient with
urothelial cancer remains in partial remission at 19 months. No
unexpected off-target toxicity was seen, and there were no
treatment-related deaths.

“We are very excited by the results of this study conducted by our
collaborators at the NCI, demonstrating the potential of TCR engineered
T-cell therapy in common solid tumors,” said David Chang, M.D., Ph.D.,
Executive Vice President of Research and Development and Chief Medical
Officer of Kite. “The KITE-718 program is built upon this proof of
concept study and incorporates Kite’s next generation T-cell
manufacturing technology that is designed to enhance cell expansion and
persistence. The findings from the NCI study will help inform us as we
advance KITE-718 for the treatment of metastatic solid cancers, for
which there is a great unmet medical need.”

KITE-718 is a single-arm, dose escalation study evaluating the safety
and efficacy of T cells engineered with the same TCR used in the NCI
study in patients with advanced cancers. KITE-718 is currently enrolling
patients. For more information on KITE-718, please visit www.clinicaltrials.gov
(NCT03139370).

About Kite

Kite is a biopharmaceutical company engaged in the development of
innovative cancer immunotherapies with a goal of providing rapid,
long-term durable response and eliminating the burden of chronic care.
The company is focused on chimeric antigen receptor (CAR) and T cell
receptor (TCR) engineered cell therapies designed to empower the immune
system’s ability to recognize and kill tumors. Kite is based in Santa
Monica, CA. For more information on Kite, please visit www.kitepharma.com.
Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. The press release may, in some cases, use terms such as
“predicts,” “believes,” “potential,” “proposed,” “continue,”
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“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements include
statements regarding intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the ability of
Kite’s next generation T-cell manufacturing technology to enhance cell
expansion and persistence and the ability to advance the clinical trial
of KITE-718 for the treatment of metastatic solid cancers. Various
factors may cause differences between Kite’s expectations and actual
results as discussed in greater detail in Kite’s filings with
the Securities and Exchange Commission, including without limitation in
its Form 10-Q for the quarter ended June 30, 2017. Any forward-looking
statements that are made in this press release speak only as of the date
of this press release. Kite assumes no obligation to update the
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press release.